An observational study in Septic Shock, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Beth Israel Deaconess Medical Center · Observational
The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used to identify morbidity, mortality, and resource utilization in patients with sepsis and septic shock.
Near-infrared spectroscopy (NIRS) noninvasively measures peripheral tissue oxygen saturation (StO2), offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving.
There are three main NIRS measurements reported in the literature: continuous StO2 measurement (StO2 initial), StO2 occlusion slope (StO2 downslope) in response to VOT testing and StO2 recovery slope (StO2 upslope) in response to vasoocclusive testing. The purpose of this study is to assesses the association of each of these parameters with severity of illness, organ dysfunction and death.
This study will utilize the Hutchinson InSpectra StO2 tissue oxygenation monitor, which is FDA approved for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation.
861 studies on the registry are indexed under Shock, Septic; 206 are open to participants now.
This study's enrollment of 186 is above the median of 100 across 298 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the Emergency Department (ED) of one of three large, urban, tertiary care facilities.
There will be three cohorts enrolled in this study: (1) Septic Shock, (2) Sepsis and (3) Controls.
Inclusion Criteria:
Listed on the Cohorts description.
Exclusion Criteria:
All patient cohorts will share common set of exclusion criteria:
Primary diagnosis of:
The SHOCK cohort will meet the American College of Chest physicians/Society of Critical Care Medicine criteria for septic shock, specifically: * 1) Suspected infection * 2) Any two of four criteria of systemic inflammatory response: * a. Temperature \> 100.4° or \< 96.8° F * b. Heart rate \> 90 beats/minute * c. Respiratory rate \> 20 breaths/min. or PaCO2 \< 32 mm Hg * d. WBC \>12,000 or \< 4000 cells/µL or \> 10% bands * 3) Hypotension despite adequate fluid resuscitation: * a. SBP \< 90 mm Hg after 20cc/kg crystalloid
Diagnostic Test: Near-infrared spectroscopy assessment
The SEPSIS cohort will to meet: * 1) Suspected infection * 2) Any two of four criteria of systemic inflammatory response: * a. Temperature \> 100.4° or \< 96.8° F * b. Heart rate \> 90 beats/minute * c. Respiratory rate \> 20 breaths/min. or PaCO2 \< 32 mm Hg * d. WBC \>12,000 or \< 4000 cells/µL or \> 10% bands * 3) Absence of refractory hypotension
Diagnostic Test: Near-infrared spectroscopy assessment
The third cohort will be comprised of uninfected ED control patients who met the criteria of no suspected infection, no SIRS criteria met and no evidence of hypoperfusion that are age and sex matched on a 1:1 basis with the shock cohort.
Diagnostic Test: Near-infrared spectroscopy assessment
The InSpectra StO2 Tissue Oxygenation Monitor (model 650; Hutchinson Technology, Hutchinson, MN, USA) with probes spaced at 15 mm will be utilized to obtain StO2 measurements. Following a minimum initial five-minute stabilization period, the initial StO2 will be measurement and then a Vasoocclusive Testing Procedure (VOT) will be performed using an automated tourniquet (Delfi Tourniquet System; Delfi Medical Innovations, Inc, Vancouver, BC, Canada), insufflated to 50 mmHg over the patient's SBP for a period of three minutes.
Also known as: NIRS assessment
Organ Dysfunction and Severity of Illness
Time frame: time 0 - 24 hrs
Mortality
Time frame: In hospital
Plan to share: Undecided
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center